A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)

Korábbi kezelés

• History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
• Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
• Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
• History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to study treatment assignment. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis.
• Active or prior documented autoimmune or inflammatory disorders (with exceptions).
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Más betegség

• Mixed small cell and non-small cell lung cancer histology.

Egyéb

• Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based CRT.

• Participant must be ≥ 18 years at the time of screening.
• Histologically-documented NSCLC and have been treated with concurrent or sequential CRT for locally advanced, unresectable (Stage III) disease.
• Documented tumour PD-L1 status by qualified lab (local or central).
• Documented EGFR and ALK wild-type status (local or central).
• Patients must not have progressed following definitive, platinum based, concurrent or sequential chemoradiotherapy.
• Participants must have received at least 2 cycles of platinum-based chemotherapy before or concurrent with radiation therapy.
• Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be enrolled. Radiation therapy should be administered by intensity modulated RT/volumetric modulated arc therapy (preferred) or 3D-conforming technique.
• WHO performance status of 0 or 1.
• Adequate organ and marrow function.